Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202305682901262 Date of Approval: 11/05/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Dexmedetomidine versus Haloperidol efficacy on intra-abdominal pressure, inflammatory response and duration of mechanical ventilation in patients with abdominal sepsis: Comparative Study Controlled by Propofol
Official scientific title Dexmedetomidine versus Haloperidol efficacy on intra-abdominal pressure, inflammatory response and duration of mechanical ventilation in patients with abdominal sepsis: Comparative Study Controlled by Propofol
Brief summary describing the background and objectives of the trial The inflammatory response associated with abdom- inal sepsis has grave consequences, including multiple organ dysfunction and death. The immunological effects of stress are mediated by cytokines, which are a group of low-molecular weight proteins which include the interleukins and interferons. They are produced from activated leucocytes, fibroblasts and endothelial cells as an early response to tissue injury and have a major role in mediating immunity and inflammation. Recently, some studies have evaluated the role of dexmedetomidine in sepsis patients with abdominal sepsis, to investigate the optimal sedative to attenuate the inflammatory response by measuring IL-6 and IL-1β serum levels before and after sedation protocol, we aimed to investigate the effects of sedation of patients with abdominal sepsis with dexmedetomidine versus sedation with propofol and effects on inflammatory mediators as IL-6, IL-8 and serum lactate level as primary goal and Intra-abdominal hypertension (IAH) as a secondary goal . The aim of current study is to compare the effects of sedating patients with intraabdominal sepsis with propofol versus dexmedetomidine or haloperidol and its effects on inflammatory response by measuring IL-6 and serum lactate level as primary outecome and effects on intraabdominal pressure , icu hospital stay and mortality as secondary outcomes.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 05/04/2023
Actual trial start date 05/04/2023
Anticipated date of last follow up 05/10/2023
Actual Last follow-up date 05/10/2023
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Propofol group 1 mg/kg loading dose over 15 minutes, after which they were given a 20–80 μg/kg/min maintenance dose. during the whole procedure Patients will receive propofol (Propofol1%, Fresenius, Fresenius Kabi, Egypt) at one mg/kg loading dose over 15 minutes, after which they were given a 20–80 μg/kg/min maintenance dose. 30 Active-Treatment of Control Group
Experimental Group Haloperidol group 2.5 mg loading then 1-2 mg / hr continuous infusion. during the whole procedure Patients will receive haloperidol at 2.5 mg loading then 1-2 mg / hr continuous infusion. 30
Experimental Group Dexmedetomidine group 1 μg/kg loading dose over 10 minutes followed by a 0.2 – 0.3 μg/kg/hr. maintenance dose. during the procedure Patients will receive dexmedetomidine (Precedex®; 200 μg/2 ml; Hospira, Inc., Lake Forest, USA) at one μg/kg loading dose over 10 minutes followed by a 0.2 – 0.3 μg/kg/hr. maintenance dose. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1-adult patients ≥ 18 years old till 70 years old 2- diagnosed with intestinal obstruction or abdominal sepsis, 3- who underwent abdominal surgery to control the source of infection and required postoperative sedation for mechanical ventilation 4- SOFA score ≥ 2 points due to intra-abdominal infection. 1- patients less than 18 years and more than 70 2- Ischemic heart diseases and heart failure 3-patient with cerebrovascular event 4- patients with neurological deficit 5-pateints with source of infection other than abdominal infection Adult: 19 Year-44 Year,Aged: 65+ Year(s) 18 Year(s) 70 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 13/02/2023 Scientific Research Ethics Committee Kafrelsheikh university faculty of medicine
Ethics Committee Address
Street address City Postal code Country
El Geish street, Kafrelsheikh , Egypt Kafrelsheikh 33511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome to investigate the effects of sedation of patients with abdominal sepsis with dexmedetomidine versus sedation with propofol and effects on inflammatory mediators as IL-6, IL-8 and serum lactate level during the whole procedure
Secondary Outcome Intra-abdominal hypertension (IAH) ,icu hospital stay and mortality during the whole procedure
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kafrelsheikh University Hospitals El geish street , Kafrelsheikh , Egypt Kafrelsheikh 33511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Sherif Kamal hafez Arafa 12 Tout Angh Amoun street Tanta 31527 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor sherif kamal hafez arafa 12 tout Angh Amiun street Tanta 31527 Egypt Individual
Secondary Sponsor sherif kamal hafez arafa 12 tout Angh Amiun street Tanta 31527 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
sherif kamal hafez arafa 12 Tout Angh Amoun street Tanta 31527 Egypt
Amir abuzikary El Sayed 23 Mohb street Tanta 31527 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator sherif arafa sherifarafa1020@gmail.com 00201005714014 12 Tout Angh Amiun street
City Postal code Country Position/Affiliation
Tanta 31527 Egypt assisstant professor of anesthesia and surgical ICU
Role Name Email Phone Street address
Public Enquiries sherif arafa sherifarafa1020@gmail.com 00201005714014 12 Tout Angh Amiun street
City Postal code Country Position/Affiliation
Tanta 31527 Egypt assisstant professor of anesthesia and surgical ICU
Role Name Email Phone Street address
Scientific Enquiries Amir Abuzikary aabozikry@yahoo.com 01016326544 23 Mohb street
City Postal code Country Position/Affiliation
Tanta 31527 Egypt assisstant professor of anesthesia and surgical ICU
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participant data that underlie the results reported in article after deidentification (text,tables,figure and appendices) Study Protocol Beginning 9 months and ending 36 months following article publication Researchers who provide a methodologically sound proposal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information